search
Back to results

Effect of Thrombus Aspiration in Patients With Myocardial Infarction Presenting Late After Symptom Onset

Primary Purpose

Myocardial Infarction

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)
Sponsored by
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ST-elevation myocardial infarction >12 and <48 hours after symptom onset
  • age 18 to 90 years
  • informed consent

Exclusion Criteria:

  • prior fibrinolysis
  • severe comorbidities with limited life expectancy
  • pregnancy
  • patient unable to give informed consent
  • participation in another trial
  • contraindications for heparin, aspirin or thienopyridines
  • contraindications for cardiac magnetic resonance examination

Sites / Locations

  • University of Leipzig Heart Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

thrombus aspiration

no thrombus aspiration

Arm Description

Manual thrombus aspiration with dedicated catheter (Export, Medtronic Inc. Minneapolis, Minnesota, USA)

Outcomes

Primary Outcome Measures

Microvascular obstruction (cardiac magnetic resonance imaging)

Secondary Outcome Measures

Full Information

First Posted
June 20, 2011
Last Updated
October 27, 2016
Sponsor
University of Leipzig
search

1. Study Identification

Unique Protocol Identification Number
NCT01379248
Brief Title
Effect of Thrombus Aspiration in Patients With Myocardial Infarction Presenting Late After Symptom Onset
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to examine the benefit of thrombus aspiration in patients with ST-elevation myocardial infarction presenting late after symptom onset.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
152 (Actual)

8. Arms, Groups, and Interventions

Arm Title
thrombus aspiration
Arm Type
Experimental
Arm Description
Manual thrombus aspiration with dedicated catheter (Export, Medtronic Inc. Minneapolis, Minnesota, USA)
Arm Title
no thrombus aspiration
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)
Intervention Description
manual thrombus aspiration catheter to be used during percutaneous coronary intervention
Primary Outcome Measure Information:
Title
Microvascular obstruction (cardiac magnetic resonance imaging)
Time Frame
1-4 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ST-elevation myocardial infarction >12 and <48 hours after symptom onset age 18 to 90 years informed consent Exclusion Criteria: prior fibrinolysis severe comorbidities with limited life expectancy pregnancy patient unable to give informed consent participation in another trial contraindications for heparin, aspirin or thienopyridines contraindications for cardiac magnetic resonance examination
Facility Information:
Facility Name
University of Leipzig Heart Center
City
Leipzig
ZIP/Postal Code
04289
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
26793952
Citation
Desch S, Stiermaier T, de Waha S, Lurz P, Gutberlet M, Sandri M, Mangner N, Boudriot E, Woinke M, Erbs S, Schuler G, Fuernau G, Eitel I, Thiele H. Thrombus Aspiration in Patients With ST-Segment Elevation Myocardial Infarction Presenting Late After Symptom Onset. JACC Cardiovasc Interv. 2016 Jan 25;9(2):113-22. doi: 10.1016/j.jcin.2015.09.010.
Results Reference
derived

Learn more about this trial

Effect of Thrombus Aspiration in Patients With Myocardial Infarction Presenting Late After Symptom Onset

We'll reach out to this number within 24 hrs